Knee Osteoarthritis
Conditions
Brief summary
This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Interventions
OTHEROzone - oxygen Therapy
Ozone gas is a structurally unstable molecule that contains three oxygen atoms.
OTHERCorticosteroid
1 ml betamethasone
Sponsors
Sisli Hamidiye Etfal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 40-85 years old, * have experienced knee pain and/or limited joint range of motion for at least 6 months, * have a diagnosis of KOA supported by radiographic imaging.
Exclusion criteria
* patients had undergone knee joint surgery, * had a history of previous intra-articular injections, * had any rheumatological disease or malignancy, * being pregnant, * had pain radiating to the knee and leg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Pain Score | 4 weeks after the first dose of treatment | Pain status of the patients was questioned with a scale between 0-10 |
| Western Ontario and McMaster Universities Arthritis Index | 4 weeks after the first dose of treatment | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:\[1\] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Pain Score | 12 weeks after the first dose of treatment | Pain status of the patients was questioned with a scale between 0-10 |
| Western Ontario and McMaster Universities Arthritis Index | 12 weeks after the first dose of treatment | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:\[1\] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties |
Countries
Turkey (Türkiye)
Outcome results
None listed